CMS’s Fixed-Dose Drug Proposal Will Hurt Patients

As a community oncology practice leader and a cancer patient advocate, we know innovation is about far more than developing new medicines; it is also about finding better ways to deliver them. Patients don't just ask whether a treatment works—they ask how it will affect their daily lives. Will they have to spend hours in an infusion center? Will they need a port? Will treatment allow them to keep working, caring for family, or simply enjoying more time at home? Unfortunately, CMS's proposed changes to the Medicare Drug Price Negotiation Program threaten to undermine advances that have made cancer treatment less burdensome for many patients.

One of the most meaningful improvements we've seen in recent years has been the development of subcutaneous versions of therapies that previously required lengthy intravenous infusions. For many patients, receiving treatment as a simple injection—much like getting a vaccine—is a completely different experience from spending hours connected to an IV in an infusion chair. An infusion appointment often means traveling to the cancer center, accessing an implanted port or starting an IV, waiting for pharmacy preparation, receiving treatment over several hours, and then traveling home. A subcutaneous injection can often be completed in just minutes. That translates into less disruption to patients' lives, and more time spent with family, at work, or simply living life.

But rather than recognizing the value of these patient-centered advances, CMS's proposal discourages them. By failing to appropriately value alternatives to infusion-based care, the policy creates incentives that favor more burdensome treatment settings over innovations that make care more convenient. Every patient who can safely receive an effective treatment in a matter of minutes instead of occupying an infusion chair for hours helps free up space for patients receiving therapies that can only be administered intravenously.

The proposal also disregards critical distinctions established through FDA's scientific review process. Therapies that receive separate FDA approval have undergone independent evaluation based on their own evidence, characteristics, and clinical benefits. Those scientific distinctions matter—to physicians making treatment decisions and to patients whose quality of life can be improved by advances in how therapies are delivered. Treating these therapies as though they are the same qualifying single-source drug ignores those meaningful differences.

Most concerningly, this policy also disincentivizes future innovations. Developing new formulations, improved delivery methods, and more patient-friendly approaches requires years of scientific investment, clinical research, and regulatory review. If Medicare fails to recognize the value of those improvements, it sends the message that making treatment easier for patients is not worth pursuing. That would be a mistake. Patients deserve not only new medicines, but better ways to receive them.

Every day, we see how much these advances matter to the people living with cancer. Whether through community oncology practices or conversations with patients and families across the country, the message is the same: innovations that reduce the burden of treatment make a meaningful difference in people's lives. CMS should reject a policy that undervalues meaningful innovation, limits patient choice, and weakens incentives to develop treatments that improve patients' quality of life.

As CMS considers whether to finalize this policy, the agency should listen to the physicians, patients, caregivers, and advocates who have spoken up, and ensure that Medicare policies continue to support the kinds of innovations that make a real difference in patients' lives.

 

Kathy W. Oubre, MS, is chief executive officer of the Coalition of Hematology and Oncology Practices and chief operating officer of Pontchartrain Cancer Center in Louisiana.

Andrew Spiegel, Esq., is co-founder and chief executive officer of the Global Colon Cancer Association. He previously co-founded and led the Colorectal Cancer Alliance and serves on the steering committee of the Alliance for Safe Biologic Medicines.



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